Diaper Wound Isolation Method used to treat excoriated diaper dermatitis

ABSTRACT

A Method to treat excoriated diaper area or diaper wounds is disclosed including utilizing a porous wound covering and placement of at least one medicament on a distal surface of said covering, whereby said method results in shorter healing time.

INDEX TO RELATED APPLICATIONS

This application is a non-provisional of, and claims benefit to each ofU.S. Provisional Patent No. 61/981,605 filed Apr. 18, 2014; 62/007,744,filed Jun. 14, 2014, and 62/150,168, filed Apr. 20, 2015, thedisclosures of which are incorporated herein by reference in theirentirety.

BACKGROUND OF THE INVENTION

Diaper Dermatitis (DD) is an inflammatory condition that affectsNeonatal Intensive Care Unit (NICU) patients worldwide. Barrier productsin the form of creams and pastes are mainstay treatment. Once paste orcream is applied, it is stuck to the diaper offering less protection ofthe skin from excrements. Babies are developmentally incontinent; thezone exposed to excrements must be protected with a more durable productto protect present excoriation and prevents new excoriation of skin inthis zone. This product changes current practice. It provides a newapproach to the management of an old problem.

SUMMARY OF THE INVENTION

Presently there is no set method to care for excoriated diaperdermatitis. Creams and pastes are the mainstay treatment for thisproblem because these wounds began as rashes. The Diaper Wound IsolationMethod (DWIM) of the present invention was developed with the idea ofchanging the management of excoriated diaper dermatitis by redefiningthis skin condition from that of a rash to that of a wound. Thisredefinition of the rash to a wound provided a new opportunity for adifferent approach; hence, as a wound the availability of products andthe method to manage changes.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a top perspective view demonstrating placement of gauze oninfant according to one embodiment the present invention.

FIG. 2 is a rear perspective view demonstrating placement of gauze on aninfinite point to one embodiment of the present invention.

FIG. 3 is a rear perspective view demonstrating placement of at leastone medicament on the distal side of the gauze according to oneembodiment of the present invention.

FIG. 4 is a rear perspective view with the gauze or partially removedand showing medicaments that has passed through the previously placedgauze.

FIG. 5 is a front perspective view with the gauze or partially removedand showing medicaments that has passed through the previously placedgauze.

FIG. 6 is a front perspective view demonstrative of placement of asecondary material over the positioned gauze as demonstrated in FIGS. 1through 5.

FIG. 7 is a rear perspective view demonstrative of placement of asecondary material over the positioned gauze as demonstrated in FIGS. 1through 5.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention is a system and method for treating andameliorating excoriated diaper dermatitis (EDD). This condition issignificantly more severe than the conventionally observed diaper rash.Patients with this condition can experience severe pain, discomfort,bleeding, and possibly permanent skin damage. The system and method ofthe present invention goes against conventional wisdom that requiresapplication of a medicament directly onto the affected skin area.

The present invention has discovered that a treatment regimen thatincludes a porous barrier directly upon the skin and application of atleast one medicament onto the distal surface of the porous barrierprovides significantly improved efficacy in the treatment of EDD.

System 10 includes a porous barrier 12. Suitable porous barriers includeparticular gauze and gauze like materials as described herein that areformed with materials that do not ordinarily irritate skin surfaces.Porous barrier 12 is placed upon patient 14 as demonstrated by thefigures. Placement is generally at or around the waist line on the frontof the patient is extending past the genital region, under the trunk andbetween the legs, and terminating above the buttocks at or near thewaistline on the back of the patient.

At least one medicament 16 is placed on the distal or outer surface ofporous material 12. It is contemplated that by placing the medicament onporous material 12 and not placing it directly upon the skin of thepatient, a microenvironment is created whereby there are certain areasin which medicament is not present on the skin of the sort of a patient.This microenvironment allows for increased healing of EDD.

A secondary cover 18 is placed over porous material 12 whereby secondarycover is constructed and arranged to be securely fastened and to holdporous material 12 in a substantially fixed position.

This product is like a skin. It will create a micro-environment aroundthe excoriated area and when used in accordance with the DWIM it willnot only protect or isolate the diaper wound from continued exposure tourine and stool; but also, from trauma relating to commercial productsand harmful caregiving practices of wiping, dabbing, and scrubbing. Thisproduct is designed to work in conjunction with a protective barrierpaste. It is designed for diaper wounds or wounds in the diaper areathat are superficial and/or partial thickness in nature that began as arash.

This invention is an improvement on what currently exists. Currentlythere are only creams and paste being used to manage diaper excoriationsin babies. Also, caregivers using those methods vary in their practices.This dressing is designed to be part of a method—The Diaper woundisolation method (DWIM) that standardizes practice as well as provide aninfrastructure for alternate medical management as in cases complicatedwith mycosis. This dressing in the short term can be impregnated to beused for similar type diaper excoriation across the lifespan in human,and in the long term, it can be designed for safe use under phototherapyfor hospitalized newborns with excoriated DD.

CHARACTERISTICS OF THE DIAPER WOUND DRESSING:

1. This is a dressing that comes in male and female versions.2. Shaped to match the convexity of the body, like a sanitary pad, butwider.3. It is ultra-thin and perforated like a mesh to make the dressingbreathable.4. Male dressing has an almond shaped opening for the genitalia.5. Female dressing has an oval or teardrop shaped opening for thegenitalia.6. Dressing comes with potential for perforation to expose the anus oncedressing is applied.7. Dressings will be supplied individually packaged in a peel and usedfashion similar to disposable gloves/sanitary pads.8. Dressing has the potential to be impregnated with medication.9. Dressing may have an optional adherent agent to both extreme ends.Adherent agent is intended to be non-stripping or non-irritating andserves to keep dressing in place.10. Dressing is designed to be used in conjunction with a barrier paste.11. Dressing is designed to be changed every diaper change without theworry of disruption of the epithelialization process.12. Dressing is designed to be irrigated in place if needed.13. Dressing is part of the Diaper Wound Isolation Method (DWI Method).

Dressing Design

This dressing will be made from products that are safe for the pretermand/or term newborn's skin. Dressing will be anatomically shaped formale and female. Male dressing will be almond shaped and female will betear drop shaped.

Dressing will have a gauze infrastructure and thread formation in amatrix or lattice design. Gauze will be cellulose/silicone impregnated.Dressing is designed to be wider than a sanitary pad, it will bebreathable, non-occlusive, non-stripping, non-adherent, designed totolerate irrigation, and has the potential to be impregnated withmedication.

How Dressing Works

This product is constructed and used with a protective barrier pastethat is applied generously once the dressing is in place. The dressingcan be left in place undisturbed preferably, but can be changed withoutinterrupting the healing process. The area will be irrigated with eachdiaper change with normal saline solution. A new dressing and coat ofbarrier paste will be reapplied. No commercial wipes are allowed. Theact of wiping, dabbing, drying is not allowed.

Summary of Use of Dressing

-   -   1. THE DRESSING BY DESIGN IS ANATOMICAL BREATHABLE,        NON-OCCLUSIVE, AND NON-ADHERENT AND SERVES TO ISOLATE THE WOUND.    -   2. THE DRESSING'S POSITION IS FORTIFIED BY THE APPLICATION OF A        PROTECTIVE BARRIER PASTE.    -   3. THE DRESSING IS FIRST PART OF THE DIAPER WOUND        MICRO-ENVIRONMENT WHICH MUST BE PRESERVED TO PROTECT THE        RE-EPITHELIALIZATION PROCESS. THEREFORE, NO COMMERCIAL WIPES,        ACT OF WIPING, DABBING, DRYING IS ALLOWED POST IRRIGATION        BETWEEN DIAPER CHANGES.

Experimental Data and Results

Cases were diagnosed with excoriated diaper dermatitis by Medical Doctor(MD) and were referred post treatment with other conventional methods.

This method, referred to as the diaper wound isolation method (DWImethod) creates a micro-environment in which the diaper wound is firstisolated with a non-adherent silicone dressing which is then supportedwith a generous application of a high concentration petrolatum/zincpaste. The diaper wound is then irrigated between diaper changes withnormal saline to decrease the bio-burden of the wound—the bio burdenbeing the excrement from stool and urine. Caretakers are as different astheir practices and may delay or increased the healing time of thesewounds. Consequently, no commercial wipes, act of wiping, dabbing ordrying is allowed between diaper changes because the high petrolatumcontent of the protective barrier paste repels the liquid. Also, if theprotective barrier was applied generously, excrement will make contactfirst with this layer, while the wound remains protected by the siliconedressing. A new dressing is applied at each diaper change. Protectivebarrier paste is then re-applied generously. This process is repeated ateach diaper change.

This process is continued until wound is fully healed. Because thesewounds are primarily superficial and affect primarily the epidermallayer of the skin, they can be classified as partial thickness injuries.Most partial thickness wounds, when treated appropriately as perevidence will heal within seven (7) days of wound treatment.Consequently, seven days was used as the possible duration using theDWIM. The cases looked at so far showed consistent progress either beingfully healed or almost healed at time of discharge. Some cases weredischarge home midway while on treatment. All products needed, exceptfor anatomical dressing, are marketed individually; but can be assembledin a kit for single personal use. A generic silicone dressing was usedin strip form in the clinical quality improvement project using theDWIM. The anatomical dressing is discussed in another provisionalpatent.

Case Study 1

A 35 week gestational age Hispanic male neonate with a birth weight of1.735 kilograms was delivered via emergent cesarean section(C/S). He wasadmitted to the NICU for respiratory distress, sepsis, possible geneticmalformation relating to trisomy 18, feeding intolerance, andgastro-esophageal regurgitation disorder (GERD). He had frequent stoolsthat led to the excoriation of the buttocks and base of his scrotum. TheDD was treated by routine NICU regimen that included nystatin cream andexposure to air/oxygen for 20 days without improvement. The DWI methodwas initiated at day 20 of failed routine DD treatment for a total of 7days. After 7 days of the DWI method, the diaper wound was significantlyimproved.

Case Study 2

A 31 weeks gestational age African American female neonate with a birthweight of 1.485 kilograms delivered via emergent c/s. She was admittedto the NICU for tachypnea of the newborn versus pneumonia, possiblesepsis due to prolonged rupture of membrane (PROM), andhyperbilirubinemia. She developed DD 1 day after admission. The infant'sDD was treated by routine NICU diaper regimen with blow-by oxygen, magicpaste made from questran, and nystatin cream for 7 days. The DD hadbecome larger, deeper and more inflamed and was classified as a wound.The routine method was discontinued and The DWI method was initiated.After 4 days using the DWI method the wound was mostlyre-epithelialized. Pt was discharged home on day four of treatment priorto the completion of treatment.

Case Study 3

A 36 weeks gestational age African American male with a birth weight4.485 kilograms. He was delivered via repeat cesarean section. He wasadmitted to the NICU for infant of a diabetic mom (IDM), transienttachypnea of the newborn (TTN) versus pneumonia, possible sepsis due tounknown maternal group beta streptococcus (GBS) status, andcardiomegaly. He developed a DD that was treated with magic paste atfirst and then vitamin A & D ointment. The magic paste used consisted ofilex paste, aquaphor, and aluminum hydroxide and it was used for two (2)days. Vitamin A & D ointment was also used for two (2) days. The DWImethod was initiated after four days of failed DD treatment. The woundwas completely re-epithelialized by four (4) days of treatment.

Case Study 4

This is a 28 weeks Caucasian female Twin A, who was 0.715 kilogram atbirth. She was delivered via emergent c/s. She was admitted forprematurity, respiratory distress syndrome (RDS), neonatal sepsis,hyperbilirubinemia, hyponatremia, and DD. She had frequent stools whichled to the excoriation of her buttocks. She received zinc oxide for 20days. She was then changed to magic paste which was a formulation ofzinc, nystatin, cholestyramine and treated for eight days additional.Clinical condition continues to worsen and the DWI method was initiatedafter 28 days of failed DD management. The wound was completelyre-epithelialized by seven (7) days of initiation of treatment.

Case Study 5

This is a 28 weeks gestational age Caucasian female, Twin B, who was0.590 kilogram at birth. She was delivered via emergent c/s. Whilehospitalized, she was treated for prematurity, RDS, neonatal sepsis,hyperbilirubinemia. Pt had a DD which was treated with Bacitracinointment and then Vitamin A &D ointment for a total of 13 days. The DWImethod was initiated after 13 days of failed DD management. The woundwas completely re-epithelialized by seven (7) days of treatment.

Case Study 6

This is a 32 weeks gestational age Hispanic male who was 1.050 kilogramsat birth. He was delivered via emergent c/s. While hospitalized, he wastreated for respiratory distress syndrome, anemia, thrombocytopenia,neonatal sepsis, congenital cytomegalus virus (CMV), CMVchorioretinitis, hyperbilirubinemia, microcephaly, severeventriculomegaly, hypoglycemia, and DD. Pt had a DD that was beingtreated with nystatin cream. DD appeared significantly worse and thetreatment was changed to the DWI method, after one day of treatment. Thewound was completely re-epithelialized by six (6) days of treatment.

Case Study 7

This is a 25 weeks gestational age African American female who was 0.815kilogram at birth. She was delivered via emergent cesarean section. Shewas admitted to the NICU for respiratory distress, complete heartblockdue to maternal systemic lupus erythematous (SLE), hypotension, neonatalonset of sepsis. She developed a DD which was treated with Vitamin A & Dointment and Magic paste (cholestyramine and zinc oxide) for a total ofnine (9) days. The DWI method was initiated on the tenth (10) day offailed DD management. The wound was completely re-epithelialized byseven (7) days of treatment.

Case Study 8

This is a 31 weeks gestational age Hispanic American male who was 1.320kilogram at birth. He was delivered via emergent cesarean section due tosevere Pre-Eclampsia. He was admitted to the NICU for respiratorydistress, hypermagnesemia & feeding intolerance. He developed a DD whichwas treated with Zinc oxide initially for 2 days, and then Magic paste(Aquaphor and Nystatin) for a total of thirteen (13) days. The DWImethod was initiated on the thirteenth (13) day of failed DD management.The wound was completely re-epithelialized by seven (7) days oftreatment.

Table 1 sets forth degrees quantifying severity of the patientcondition.

TABLE 1 DIAPER WOUND EVALUATION TOOL Score Degree Definition 0 None Skinis clear(may have some very slight dryness and/or a single papule but noerythema. 0.5 Slight Faint to definite pink in a very small area(<2%);may also have a single papule and/or slight dryness. 1.0 Mild Faint todefinite pink in a small area(2%-10%) or definite redness in a verysmall area(<2%) and/or scattered papules and/or slight dryness/scaling.1.5 Mild/ Faint to definite pink in a larger area(10%) or Moderatedefinite redness in a small area(2%-10%) or very intense redness in avery small area(<2%) and/or scattered papules(<10% area) and/or moderatedryness/scaling. 2.0 Moderate Definite redness in a larger area(10%-50%) or very intense redness in a very small area(<2%) and/orsingle to several areas of papules(10%-50%) with five or fewer pustules,may have slight desquamation or edema. 2.5 Moderate/ Definite redness ina very large area(>50%) or very Severe intense redness in a small area(2%-10%) without edema and/or larger areas(>50%) of multiple papulesand/or pustules; may have moderate desquamation and/or edema. 3.0 SevereVery intense redness in a larger area (>10%) and/or severe desquamation,severe edema, erosion and ulceration; may have large areas of confluentpapules or numerous pustules/vesicles.

TABLE 2 CASE STUDIES DATA CASES DAY 1 DAY 3-4 DAY 7 1 3 1.5 0.5 2 3 0.5Pt discharged home 3 3 0.5 Pt discharged home 4 2 1.0 0 5 2 0.5 0 6 30.5 0 7 2.5 1.0 0 8 3.0 1.0 0

Table 2 is a table of values quantifying patient condition and progress.

Data Summary

The evaluation of cases presented shows that regardless of the clinicalcourse, gestational age, and other clinical factors affecting thesepatients, there is consistency in the progression of healing using theDWI method. Re-epithelialization of the wound is evident from the onsetof treatment. The healing time of diaper wounds is decreased using theDWI method. The DWI method was effective, although it required a fewmore steps in the management of these patients.

The Version of the Method or Invention Discussed Here Involves:

1. A non-adherent, breathable silicone dressing

2. A Protective Barrier Paste

3. Normal Saline solution4. A 30-35 mls syringe designed with a 19 gauge catheter tip.5. Barrier Field (optional)

Relationship Between the Components:

The non-adherent, perforated silicone dressing will be applied to thecleansed wound in the diaper area. This isolates the wound, but allowsit to breathe and be exposed to the medicinal properties of the pastethat will be applied. Step 2. Skin protective barrier paste is appliedto support the micro-environment of the wound created by the dressing.When the baby stools/urinates the excrement will get to the protectivepaste first. At the time of the diaper change, the dressing is removedand site is irrigated. Step 3. The catheter tipped syringe is used tocollect the normal saline used in the irrigation. Syringe is chosenbecause it adds pressure to clean site vs. the traumatic exposure thatcomes from wiping or cleaning done by caretakers. Wiping, dabbing,scrubbing, and using commercial products will disturb there-epithelialization of the wound and delay healing. The normal salineis chosen because of its non-pyrogenic properties.

This is the isolation of diaper wounds by the creation of amicro-environment using a breathable, non-occlusive, non-adherentdressing; then, supporting this area with a protective barrier paste.Diaper wound site is irrigated at each diaper change. No commercialwipes, act of wiping, dabbing or scrubbing at site during diaperchanges. New dressing is applied and protective barrier paste is appliedover the dressing generously. Patient (Pt) is allowed to be bathed asusual, but extra care is taken to cleanse wound site during that time.It is recommended to apply a small amount of soap in hand and gentlycaress wound site during bathes. This method is repeated throughoutdiaper changes for Seven (7) days.

How to Make the Invention:

This is a method, and products will be assembled in a convenient kit.Kit will contain:

-   -   1. A silicone impregnated gauze dressing which is designed in a        single peel away ready to use fashion—similar to female sanitary        napkins, the only difference it will be anatomically shaped to        be male/female, thin, breathable or porous, and non-adherent.        The dressing is discussed in another provisional patent.    -   2. Normal saline,    -   3. Protective barrier paste    -   4. A 30 mls syringe with a 19 gauge catheter tip.    -   5. A re-usable changing pad.

How to Use the Invention:

-   -   1. Cleanse site in the normal fashion of bathing initially.    -   2. Then irrigate with normal saline.    -   3. Apply silicone dressing.    -   4. Apply generous amount of barrier paste.    -   5. Dress infant as usual.    -   6. Irrigate with normal saline each diaper change.    -   7. No wiping, drying, or commercial wipes allowed.    -   8. Re-apply a generous amount of barrier paste each diaper        change.

Notes

Between diaper changes, there is no need to attempt to dry wound postirrigation because there is a natural repellence to the liquid irrigantdue to the high petrolatum content of the Sensi-Care.

Caregivers are instructed to not attempt to clean residual Sensi-Careprotective barrier from the wound because of the possibility ofre-injuring of the diaper wound.

The 19-gauge catheter tip is likened to a power hose. It allows for thegeneration of adequate psi (4-15) for the cleansing of the wound site asbest as possible.

Provide daily baths as usual, but diaper area should be gently cleansedto keep fresh.

Avoid scrubbing, abrasive materials to wound area. Rationale: Roughcleaning, abrasive clothes will disturb the re-epithelialization processof the wound and delay or worsen wound.

If there is stool stuck to the barrier paste, during bath time simpleplace a very small portion of soap in your gloved hand (if in hospital)or in the palm of your hand at home and gently caress wound site. Theaim of bath during this time is for comfort and hygiene; fine detailswill be possible once wound is fully healed.

Diaper excoriations are primarily partial thickness wound types. Thesewounds were evidenced as having a healing time of seven (7) days.

Wounds that extend beyond the healing time of 7 days while using theDWIM as instructed, may be related to other serious pathologies or skinabnormalities. MD should be notified for consults from specialists suchas: Dermatologist/Rheumatologist/oncologist, etc.

While the invention has been described in its preferred form orembodiment with some degree of particularity, it is understood that thisdescription has been given only by way of example and that numerouschanges in the details of construction, fabrication, and use, includingthe combination and arrangement of parts, may be made without departingfrom the spirit and scope of the invention.

I claim:
 1. A method for treating excoriated diaper dermatitis, saidmethod comprising the steps of: cleaning an infected area of a patient;providing a properly sized porous gauze; placing said gauze ontoinfected area; placing at least one medicament on top of said gauze;covering said gauze with a covering constructed and arranged to securesaid cause into a substantially fixed position.
 2. The method of claim 1wherein said placing on infected area includes placing on a patientabove genitalia and buttocks of a patient.
 3. The method of claim 1whereby said method demonstrates at least 50% improvement in severity ofexcoriated diaper dermatitis after three days of treatment.
 4. Themethod of claim 1 whereby said method demonstrates at least 90%improvement in severity of excoriated diaper dermatitis after seven daysof treatment.
 5. The method of claim 1 wherein said providing a properlysized porous gauze includes providing a particular gauze configured fora male patient or a particular gauze configured for a female patient. 6.The method of claim 1 wherein said method is repeated at each diaperchange.
 7. The method of claim 1 wherein said method includes providinga kit, said kit including: a silicone impregnated gauze dressingconfigured in a single peel away ready to use fashion said gauze beinganatomically shaped for either male or female, wherein said gauze is athin, breathable or porous, and non-adherent; normal saline; at leastone medicament; a syringe; and a A re-usable changing pad.
 8. The methodof claim 1 wherein said medicament is a protective barrier paste